- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02058563
Immunogenicity and Safety of GSK Biologicals' Combined Measles-mumps-rubella Vaccine in Volunteers, Seven Years of Age and Older
Immunogenicity and Safety Study of GSK Biologicals' Combined Measles-mumps-rubella Vaccine in Subjects Seven Years and Older (209762)
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Tartu, Estonia, 50106
- GSK Investigational Site
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Bratislava, Slovakia, 851 01
- GSK Investigational Site
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Dolny Kubin, Slovakia, 026 01
- GSK Investigational Site
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Dunajska Streda, Slovakia, 929 01
- GSK Investigational Site
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Martin, Slovakia, 036 01
- GSK Investigational Site
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Ruzomberok, Slovakia, 034 01
- GSK Investigational Site
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Zlate Moravce, Slovakia, 953 01
- GSK Investigational Site
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Alabama
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Birmingham, Alabama, United States, 35211
- GSK Investigational Site
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Arizona
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Chandler, Arizona, United States, 85224
- GSK Investigational Site
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Mesa, Arizona, United States
- GSK Investigational Site
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Florida
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Miami, Florida, United States, 33176
- GSK Investigational Site
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Miami, Florida, United States, 33144
- GSK Investigational Site
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Illinois
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Chicago, Illinois, United States, 60654
- GSK Investigational Site
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Minnesota
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Edina, Minnesota, United States, 55435
- GSK Investigational Site
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Missouri
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Saint Louis, Missouri, United States, 63141
- GSK Investigational Site
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Ohio
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Cincinnati, Ohio, United States, 45249
- GSK Investigational Site
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Texas
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San Antonio, Texas, United States, 78229
- GSK Investigational Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Subjects who the investigator believes that they and/or their parent(s) or Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol.
- Male or female subjects 7 years of age or older and born after December 31, 1956*. *The only exception to this is health care workers born before 1957 without other evidence of immunity to mumps for which one dose of a live mumps virus vaccine is recommended; therefore this population is eligible for enrollment in this study.
For all children 7-17 years of age:
- Written documentation of prior receipt of 1 dose of MMR vaccine administered on or after the first birthday.
For all adults 18 years of age and older:
- Prior receipt (written or verbal history) of at least one dose of MMR vaccine.
- Birth in the US.
- Written informed consent obtained from the subject or from the parent(s)/LAR(s) of the subject (assent will be obtained from subjects who are still legally minors in line with local rules and regulations).
- Subjects in stable health as determined by investigator's physical examination and assessment of subjects' medical history.
Female subjects of non-childbearing potential may be enrolled in the study.
- Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, or ovariectomy or post-menopause.
Female subjects of childbearing potential may be enrolled in the study, if the subject
- Has agreed to be abstinent or practiced adequate contraception during the entire period starting 30 days prior to vaccination(s) until 3 months after receipt of the study vaccination and
- has a negative pregnancy test on the day of vaccination.
Exclusion Criteria:
- Child in care.
For all children 7-17 years of age:
- Previous receipt of more than 1 dose of a measles-containing vaccine.
- Use of any investigational or non-registered product other than the study vaccine(s), during the period starting 30 days preceding the day of study vaccination, (i.e. 30 days prior to Day 0) or planned use during the entire study period.
- Receipt of any measles, mumps or rubella-containing vaccine during the period starting 42 days before the day of study vaccination (i.e. 42 days prior to Day 0).
- Chronic administration (defined as 14 or more consecutive days) of immunosuppressants or other immune-modifying drugs during the period starting 180 days before study vaccination or any planned administration of immune-modifying drugs during the entire study. Inhaled and topical steroids are allowed.
- Administration of immunoglobulins and/or any blood products during the period starting 180 days prior to study vaccination through the immunogenicity evaluation at Visit 2 or Visit 3 (for one-dose or two-dose cohort, respectively).
- Planned administration/ administration of any live viral vaccine not foreseen by the study protocol during the period starting 30 days prior to study vaccination and ending at Visit 2. Live intranasal influenza vaccine or any inactivated vaccine required in the age group may be given at any time, including the day of study vaccination.
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
- History of measles, mumps, or rubella disease.
- Known exposure to measles, mumps, or rubella, during the period starting 30 days before study start (i.e. 30 days prior to Day 0).
- %
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: INV_MMR Group
Subjects will receive 1 dose of GSK Biologicals' trivalent Measles, Mumps, and Rubella Virus Vaccine (Priorix®).
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1 dose administered as a subcutaneous (SC) injection.
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Active Comparator: COM_MMR Group
Subjects will receive 1 dose of Merck's M-M-R®II, Measles, Mumps, and Rubella Virus Vaccine.
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1 dose administered subcutaneously.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Anti-measles Virus Antibody Concentrations.
Time Frame: At Day 42
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Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in milli International Units per milliliter (mIU/mL).
Seropositivity was defined as subjects with anti-measles virus antibody concentration equal or greater than 150 mIU/mL.
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At Day 42
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Anti-mumps Virus Antibody Concentrations
Time Frame: At Day 42
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Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in EU/mL.
Seropositivity was defined as subjects with anti-mumps virus antibody concentration equal or greater than 5 EU/mL
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At Day 42
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Anti-rubella Virus Antibody Concentrations.
Time Frame: At Day 42
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Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in IU/mL.
Seropositivity was defined as subjects with anti-rubella virus antibody concentration equal or greater than 4 IU/mL
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At Day 42
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Threshold of 200 mIU/mL (Seroresponse Rate)
Time Frame: At Day 42
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Seroresponse was defined as: Anti-measles virus antibody concentration equal to or above the threshold of 200 mIU/mL after administration of INV_MMR vaccine vs. COM_MMR at Day 42. |
At Day 42
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Number of Subjects With Anti-mumps Virus Antibody Concentration Equal or Above the Threshold of 10 EU/mL (Seroresponse Rate).
Time Frame: At Day 42
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Seroresponse was defined as: Anti-mumps virus antibody concentration equal to or above the threshold of 10 EU/mL after administration of INV_MMR vaccine vs. COM_MMR at Day 42. |
At Day 42
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Number of Subjects With Anti-rubella Virus Antibody Concentration Equal or Above the Threshold of 10 IU/mL (Seroresponse Rate).
Time Frame: At Day 42
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Seroresponse was defined as: Anti-rubella virus antibody concentration equal to or above the threshold of 10 IU/mL after administration of INV_MMR vaccine vs. COM_MMR at Day 42. |
At Day 42
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Number of Subjects Who Achieved a 4-fold or Greater Rise in Anti-measles, Anti-mumps and Anti-rubella Virus Antibody Concentrations.
Time Frame: At Day 42
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For subjects with seronegative status at pre-vaccination, a 4-fold rise in antibody concentration is defined as 4 times the cut-off level of the assay.
Cut-off levels for anti-measles, anti-mumps and anti-rubella virus antibody concentrations are 150 mIU/mL, 5 EU/mL and 4 IU/mL.
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At Day 42
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Number of Subjects With Solicited Local Symptoms
Time Frame: During the 4-day (Days 0-3) post-vaccination period
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Assessed solicited local symptoms were pain, redness and swelling.
Any = Occurrence of any local symptom regardless of their intensity grade.
Grade 3 Pain = Significant pain at rest.
Prevented normal every day activities.
Grade 3 redness = redness with surface diameter >50mm.
Grade 3 swelling = swelling with surface diameter >50mm.
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During the 4-day (Days 0-3) post-vaccination period
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Number of Subjects Reporting Fever
Time Frame: During the 43 days (Days 0-42) post-vaccination period.
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Fever was assessed:Any fever (≥38°C) = occurrence of any fever regardless of its intensity grade or relationship to vaccination.
Grade3 fever = fever >39.5°C. .
Related = symptom assessed by the investigator as causally related to study vaccination.The preferred route for recording temperature in this study was oral.
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During the 43 days (Days 0-42) post-vaccination period.
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Number of Subjects Reporting Solicited General Symptoms as Parotid/Salivary Gland Swelling and Any Sign of Meningism/Seizure.
Time Frame: During the 43 days (Days 0-42) post-vaccination period.
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Assessed MMR specific symptoms were parotid/salivary gland swelling and any sign of meningism/seizure.
Parotid/salivary gland swelling: Any = occurrence of any general symptoms regardless of their intensity grade or relationship to vaccination; Grade 3 Parotid/salivary gland swelling = Swelling accompanied with general symptoms.
Meningism/seizure: Any= occurrence of any general symptoms regardless of their intensity grade or relationship to vaccination; Grade-3 meningism/seizure= Prevented normal, everyday activities (In adults/adolescents, such an AE could, for example, prevented attendance at work/school and could necessitated the administration of corrective therapy).
Related symptom = symptom assessed by the investigator as causally related to study vaccination.
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During the 43 days (Days 0-42) post-vaccination period.
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Number of Subjects Reporting Unsolicited AEs
Time Frame: During the 43 days (Days 0-42) post-vaccination period.
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Any untoward medical occurrence in a patient or clinical investigation child, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product
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During the 43 days (Days 0-42) post-vaccination period.
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Number of Subjects Reporting Solicited Rash Symptom
Time Frame: During the 43 days (Days 0-42) post-vaccination period.
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Assessed any rash, Grade 3, Related, Localized rash, Generalized rash,measles/rubella-rash. Any= occurrence of any general symptom regardless of its intensity grade or relationship to vaccination.
Grade3 rash/exanthema= Rash which prevented normal, everyday activities (In adults/adolescents, such an AE could, for example, prevented attendance at work/school and could necessitated the administration of corrective therapy).
Grade 3 measles/rubella/varicella-like rash = Rash with more than150 lesions.
Related = symptom assessed by the investigator as causally related to study vaccination.
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During the 43 days (Days 0-42) post-vaccination period.
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Number of Subjects Reporting Solicited Joint Pain (Arthralgia/Arthritis)
Time Frame: During the 43 days (Days 0-42) post-vaccination period.
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Assessed any, Grade-3, Related.
Any= occurrence of any general symptom regardless of its intensity grade or relationship to vaccination; Grade3 joint pain (arthralgia/arthritis)= Pain which prevented normal, everyday activities (In adults/adolescents, such an AE could, for example, prevented attendance at work/school and could necessitated the administration of corrective therapy).
Related = symptom assessed by the investigator as causally related to study vaccination.
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During the 43 days (Days 0-42) post-vaccination period.
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Number of Subjects Reporting NOCDs
Time Frame: Day 0 through the end of the study (Day 180)
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Occurrence of new onset chronic diseases (NOCDs)
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Day 0 through the end of the study (Day 180)
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Number of Subjects Reporting Adverse Events Prompting ER Visits
Time Frame: Day 0 through the end of the study (Day 180)
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Occurrence of AEs prompting emergency room (ER) visits.
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Day 0 through the end of the study (Day 180)
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Number of Subjects Reporting Serious Adverse Events (SAEs)
Time Frame: Day 0 through the end of the study (Day 180)
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A serious adverse event (SAE) is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity.
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Day 0 through the end of the study (Day 180)
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Stomatognathic Diseases
- Mouth Diseases
- Morbillivirus Infections
- Paramyxoviridae Infections
- Mononegavirales Infections
- Salivary Gland Diseases
- Togaviridae Infections
- Rubivirus Infections
- Rubulavirus Infections
- Parotitis
- Parotid Diseases
- Measles
- Rubella
- Mumps
Other Study ID Numbers
- 115231
- 2011-003672-36 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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